The Effect of GRAVITY on Physiological Measurements During Invasive Coronary Angiography and Intervention

NCT03097172 | Completed

• 1 other identifier: B905
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single centre observational study on the impact of change in patient position and hence gravity, on physiological measurements in coronary arteries. When patients present with heart attacks involving completely occluded heart arteries, there are signs anecdotally and in literature that arteries sitting higher up with the patient lying flat, receive less blood supply than arteries sitting lower down. The investigators believe this effect is due to the pull of gravity on the flow of blood through the heart arteries. If this is indeed the case, changing position from lying supine (patient on their back) to lying prone (patient on their front) could reverse these anatomical positions and change measurements obtained during a coronary angiogram. These measurements include pressure and flow.

Conditions

Coronary Artery Disease

Keywords

Percutaneous Coronary Intervention (PCI); Chronic Total Occlusion (CTO); Cardiac MRI; Fractional Flow Reserve (FFR); Doppler Flow Velocity; Cardiovascular Disease; Atherosclerosis; Hydrostatic Pressure

Outcome Measures

Primary Outcomes (1)

• Coronary physiology changes

  Changes in coronary physiology in the same vessel when comparing prone and supine patient position

  5 minutes

Secondary Outcomes (1)

• MRI finding

  4 weeks

Study Arms (2)

Group 1

Stable elective patients Stenotic coronary artery 10 x LAD 10 x RCA 10 x Cx 30 patients total

Group 2

Stable elective patients Chronic total occlusion of one artery 10 x LAD 10 x RCA 20 patients total

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients referred to the centre for 'pressure wire study' (group 1) or CTO PCI (group 2). Referred from secondary care to tertiary centre. Participants will be patients suffering from ischaemic heart disease living in the area served by the tertiary centre

You may qualify if:

• Age \> 18 years of age
• Angina symptoms or evidence of myocardial ischaemia
• Stenosis \>50% in LAD or RCA on coronary angiogram or CT coronary angiogram
• Participant is willing and able to give informed consent
• Eligible for PCI

You may not qualify if:

• Previous CABG with any patent grafts
• Significant left main stem stenosis
• Lesion of interest in Circumflex artery
• Haemodynamic Instability
• Unable to consent
• Unable to receive dual antiplatelet therapy
• Contraindication to adenosine
• Recent acute coronary syndrome (ACS) (\<48 hours)
• Pregnancy
• Unable to lie prone
• Severe valvular heart disease or cardiomyopathy
• Group 2
• Age \>18 years of age
• Stable angina / ischaemic symptoms / and / or
• Evidence of viability and /or ischaemia in the chronic total occlusion (CTO) territory

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead
• Anglia Ruskin University: collaborator

Study Sites (1)

The Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases; Atherosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• John R Davies, MBBS, PhD

  Essex Cardiothoracic Centre, Basildon and Thurrock University Hospitals Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: March 31, 2017
• Study Start: June 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)